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Tag: FDA

  • FDA Files MRTP Renewal for Two 22nd Century Products

    FDA Files MRTP Renewal for Two 22nd Century Products

    Today (May 12), FDA filed two modified risk tobacco product (MRTP) renewal applications for scientific review for 22nd Century Group Inc. products VLN King and VLN Menthol King. Both products are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.

    The renewal follows MRTP orders first granted in 2021, which are set to expire in December 2026, requiring FDA reauthorization for continued marketing with reduced-risk claims. The agency has begun releasing redacted application materials for public access and has opened a docket for public comment, allowing stakeholders to submit data and feedback as part of the review process.

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”

  • WSJ: Trump Ready to Fire Makary

    WSJ: Trump Ready to Fire Makary

    According to The Wall Street Journal, President Donald Trump signed off on a plan to remove FDA Commissioner Marty Makary, though the decision has not yet been finalized and could still change. The report, citing people familiar with the matter, said Makary has faced mounting criticism within the administration over his management of the agency, including clashes with officials at the Department of Health and Human Services and the White House. His handling of key policy areas—including drug approvals, vaccines, and vaping regulation—has drawn particular scrutiny.

    The reported move follows a turbulent period at the FDA marked by leadership turnover and internal disruptions, including recent high-profile departures and ongoing restructuring efforts. Earlier in the week, Trump reportedly criticized Makary for not moving quickly enough on authorizing flavored vaping and nicotine products, an issue that has become a point of tension within the administration.

    Makary, a former Johns Hopkins surgeon nominated in late 2024 and confirmed in 2025, has been a visible figure in the administration’s health agenda, including its “Make America Healthy Again” initiative. While no official confirmation has been issued by the White House or HHS, sources cited in the report indicated growing consensus among senior officials that a leadership change at the FDA may be imminent.

  • 22nd Century Reports $4.1M in Revenue as it Focuses on Future

    22nd Century Reports $4.1M in Revenue as it Focuses on Future

    22nd Century Group reported first-quarter 2026 revenue of $4.1 million, with a continued focus on expanding its reduced-nicotine VLN cigarette portfolio and distribution footprint. The company said it is gaining traction with adult smokers, with products now available in more than 2,000 stores across 20 states and targeting over 5,000 retail locations by the end of 2026.

    The company is positioning its proprietary low-nicotine technology as aligned with potential future FDA standards, while pursuing a broader product pipeline across cigarettes, filtered cigars and other formats. Despite ongoing net losses, 22nd Century said it is prioritizing distribution growth, regulatory engagement, and margin improvement, with plans to expand licensing opportunities and advance multiple PMTA submissions to support long-term growth.

  • FDA Expands AI Capabilities to Improve Efficiency  

    FDA Expands AI Capabilities to Improve Efficiency  

    The U.S. Food and Drug Administration announced that it launched upgraded internal AI capabilities as part of a broader modernization initiative, introducing Elsa 4.0 and a new unified data platform, HALO. The agency said the integration of more than 40 systems into HALO will allow staff to access and analyze regulatory data more efficiently, with Elsa now operating directly on consolidated datasets to support workflows across scientific review, compliance, and enforcement.

    “Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable,” said FDA Commissioner Marty Makary. “We have some of the best scientists in the world, and we need to take good care of them.”

    New features in Elsa 4.0 include document generation, data analysis tools, improved search functions, and automation capabilities, aimed at streamlining regulatory processes. The FDA said the enhanced AI infrastructure is designed to improve efficiency and support faster decision-making, with potential implications for the review and oversight of regulated products, including tobacco and nicotine products.

  • Charlie’s Holdings Talks Opportunities as FDA Flavor Stance Shifts  

    Charlie’s Holdings Talks Opportunities as FDA Flavor Stance Shifts  

    Charlie’s Holdings said it is well-positioned to capitalize on potential regulatory changes in the U.S. flavored vape market, highlighting its portfolio of 678 PMTA-submitted products and its planned rollout of age-gated devices using AI-powered verification technology. The company said its ability to combine pending applications with advanced access-restriction systems could align with evolving FDA expectations around youth prevention, positioning it to bring new products to market if approvals expand.

    The company pointed to recent reports that President Donald Trump has urged the FDA to accelerate flavored vape authorizations, along with the agency’s approval of four new ENDS products—including its first flavored pod authorizations using age-gating—as signals of a possible policy shift. Charlie’s said these developments could support broader regulatory acceptance of flavored products and create new commercial opportunities for companies able to meet stricter access and compliance requirements.

  • FDA Authorizes Four New ENDS Products

    FDA Authorizes Four New ENDS Products

    The U.S. Food and Drug Administration has authorized four Glas electronic nicotine delivery system products through the PMTA pathway, including Classic Menthol, Fresh Menthol, Gold, and Sapphire pods containing 5% nicotine. The decision marks the first FDA authorization of ENDS products beyond traditional tobacco and menthol flavors, expanding the range of legally marketed vaping products in the U.S. to 45.

    The agency said the authorization was based on evidence that the products’ device access restriction technology—requiring age verification via government ID, smartphone pairing, and biometric checks—can effectively limit youth access.

    “By helping to prevent youth use, device access restrictions are a potential game changer,” said Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “This technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable [the] availability of an expanded array of flavored options for adults who smoke who may use these products to completely switch away from regular cigarettes.”

    The FDA emphasized that marketing must be targeted to adults and that the company must monitor and report on youth prevention measures, while noting that authorization could be withdrawn if compliance requirements are not met or if youth usage increases.

  • WSJ Reports Trump Pressuring FDA to Move on Flavored Vapes

    WSJ Reports Trump Pressuring FDA to Move on Flavored Vapes

    According to The Wall Street Journal, President Donald Trump has criticized FDA Commissioner Marty Makary for not moving quickly enough to approve flavored vaping and nicotine products, raising the issue in recent discussions with advisers. The report, citing people familiar with the matter, said Trump sought input on the role of flavored products among key voter groups and questioned the pace of regulatory decisions, with some advisers describing the FDA’s approach as an obstacle to the administration’s stated position on vaping.

    The FDA has so far authorized only 41 vape products for sale in the U.S., all in tobacco or menthol flavors, maintaining a requirement for strong evidence that flavored products provide benefits to adult smokers that outweigh youth risks. According to the report, Makary has discussed the possibility of adjusting the agency’s stance, with some sources indicating he may be considering a more open approach to flavored product approvals, though no formal policy change has been confirmed.

  • 5th Circuit Considering if FDA Overstepped in Vape Flavor Regs

    5th Circuit Considering if FDA Overstepped in Vape Flavor Regs

    A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit heard oral arguments this week in a case brought by seven small vape-liquid companies challenging the FDA’s denial of marketing authorization for flavored electronic nicotine delivery systems. The companies argue the FDA rejected their applications based on a comparative efficacy requirement they say was not disclosed before the 2020 PMTA deadline, in violation of the Tobacco Control Act.

    The FDA defended the denials, saying manufacturers must prove their specific products are appropriate for the protection of public health. Government counsel argued that non-tobacco flavors add youth-use risk and that applicants failed to show added adult switching benefits over tobacco-flavored products.

    The panel questioned both sides on whether the FDA’s approach was lawful adjudication or rulemaking in practice. Courthouse News Service said, this “ruling could affect thousands of pending applications and clarify how much procedural leeway the FDA has when reviewing the flood of vape products submitted after the 2020 PMTA deadline.”

  • PMI Announces FDA Reauthorization of IQOS as MRTP

    PMI Announces FDA Reauthorization of IQOS as MRTP

    Today (April 29), Philip Morris announced that it has received renewed Modified Risk Tobacco Product (MRTP) authorizations from the U.S. Food and Drug Administration for its IQOS heated tobacco devices and associated HEETS consumables. The renewal covers two IQOS device versions and three HEETS variants, allowing the company to continue communicating reduced-exposure information to adult smokers in the U.S. The FDA said the decision is appropriate for the protection of public health, citing evidence that switching completely from cigarettes to IQOS significantly reduces exposure to harmful chemicals.

    The agency reaffirmed that available scientific evidence supports a measurable and substantial reduction in harm compared to combustible cigarettes, even without long-term epidemiological data. IQOS was first authorized through the FDA’s premarket pathway in 2019, with its initial MRTP designation granted in 2020 and expanded in subsequent years. The renewed orders maintain PMI’s position as the only company with MRTP authorizations for heated tobacco products in the U.S.

    The authorization applies to the IQOS 2.4 and IQOS 3 systems, along with HEETS Amber, Green Menthol and Blue Menthol variants. PMI said the decision supports its ongoing strategy to transition adult smokers away from cigarettes, as the company continues to invest in and expand its smoke-free product portfolio while awaiting further regulatory review of newer devices.